Pulsed Electromagnetic Field Therapy for Diabetic Foot Ulcer Sensation

NCT07696728 | Recruiting DMC

• 1 other identifier: TUF/EIRB/174/26
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes Mellitus (DM) is a chronic metabolic disorder characterized by hyperglycaemia for extended periods of time, which causes damage to peripheral nerves, resulting in sensory, motor and autonomic dysfunction. The study will aim to assess the effect of the Low pulse electromagnetic field therapy in VPT and protective sensation in the diabetic foot ulcer. The total number of participants will be 42 (calculated by epi tool) and the participants are to be divided among two groups. Non Probability Consecutive sampling technique will be used for this study. The data collection tools will be Wagner Classification System for Diabetic Foot Ulcers, Numerical Pain Rating Scale, Goniometry, 10 g monofilament, Tuning Fork 128 Hz will be used. After meeting the inclusion and exclusion criteria and taking the written and verbal informed consent participants in one group will receive (low frequency pulsed electromagnatic field therapy and ankle Range of Motion) and other group will be receive (Sham PEMF and ankle Range of motion). Both interventions will be given three times weekly (or every other day) for 6 weeks. Vibrations perception, protective sensation, pain, ankle ROM and will be the outcome measures of the study. The data will be collected at baseline and 6 weeks. The data will be analyzed by using SPSS 23 and interpreted by using MS Word.

Conditions

Diabetes Mellitus (DM)

Outcome Measures

Primary Outcomes (3)

• Vibration Perception Threshold

  Vibration perception threshold will be measured by using Tuning Fork 128 Hz. that check either the patient sense the vibration or not. if person feel sensation grater than 10 second indicate decrease vibration perception.

  6 week

• Protective Sensation Score as Assessed by the 10-g Monofilament Test (0-10 Total Score).

  Protective sensation will be assessed using the 10-g monofilament at 10 standardized plantar sites. One point is awarded for each site where the participant correctly perceives the monofilament, yielding a total score ranging from 0 to 10. Higher scores indicate better protective sensation.

  6 weeks

• Diabetic peripheral neuropathy

  Diabetic peripheral neuropathy will be measured by using Michigan Neuropathy Screening Instrument (MNSI) Physical Assessment, the decrease in score showed improvement the total score consisting of 5 per foot overall 10, 0 indicate foot is healthy and 10 indicate worse condition.

  6 weeks

Secondary Outcomes (2)

• Range of Motion

  6 weeks

• Pain intensity

  6 weeks

Study Arms (2)

Group A Pulsed Electromagnetic Field Therapy and Ankle Range of Motion

EXPERIMENTAL

Pulsed Electromagnetic Field Therapy (Tassone et al., 2025) Parameters Description PEMF Low frequency (15 Hz) Very low intensity (20 Gauss) Time duration (20 minutes) Duration 3 days a week (alternate days) Total Treatment Duration 6 weeks Table 2 Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM * Dorsiflexion * Plantarflexion * Inversion * Eversion Set 2 sets Repetition 15-20 repetition Workload 3 days/week (on alternate days) Total Treatment Period 6 weeks

Procedure: Pulsed Electromagnetic Field Therapy and Ankle Range of Motion

Group B Ankle Range of Motion

EXPERIMENTAL

Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM * Dorsiflexion * Plantarflexion * Inversion * Eversion (Levangie and Norkin, 2011) Set 2 sets Repetition 15-20 repetition Days/Week 3 days per week (on alternative days) Total Treatment Duration 6 weeks

Procedure: Ankle Range of Motion (Levangie and Norkin, 2011)

Interventions

Pulsed Electromagnetic Field Therapy and Ankle Range of Motion PROCEDURE

Pulsed Electromagnetic Field Therapy (Tassone et al., 2025) Parameters Description PEMF Low frequency (15 Hz) Very low intensity (20 Gauss) Time duration (20 minutes) Duration 3 days a week (alternate days) Total Treatment Duration 6 weeks Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM * Dorsiflexion * Plantarflexion * Inversion * Eversion Set 2 sets Repetition 15-20 repetition Workload 3 days/week (on alternate days) Total Treatment Period 6 weeks

Group A Pulsed Electromagnetic Field Therapy and Ankle Range of Motion

Ankle Range of Motion (Levangie and Norkin, 2011) PROCEDURE

Parameters Description Ankle Range of Motion Active ROM * Dorsiflexion * Plantarflexion * Inversion * Eversion (Levangie and Norkin, 2011) Set 2 sets Repetition 15-20 repetition Days/Week 3 days per week (on alternative days) Total Treatment Duration 6 weeks

Group B Ankle Range of Motion

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must have a clinical diagnosis of Type 2 diabetes (HbA1c ≥ 6.5) (Bolen et al., 2016).
• Patients with Wagner grade 1 diabetic foot ulcers was selected.
• Michigan Neuropathic Screening Instrument history score ≤7 (Viswanathan et al., 2025).
• Participants showing reduced vibration perception threshold on 128Hz Tunning fork was included to confirm the presence of sensory neuropathy Associated with diabetic ulcers (Viswanathan et al., 2025).
• Sensation on 10g monofilament less then 8 point out of 10 indicate reduces Sensation.
• Participants having diabetes for more than 10 years (Grewal et al., 2015).
• Pariticipants aged between 40 to 60 years.
• Both gender were included.
• Participants who was willing to give consent.

You may not qualify if:

• Participants who have significant cognitive impairment (e.g Dementia, Alzheimer) that would prevent them from understanding and adhering to Study instructions.
• Participants with active infections requiring systemic antibiotic therapy (Kwan et al., 2015).
• Patients with comorbidities such as malignancy, severe renal disease, or Other systemic condition.
• Participants who was not taking any medicine

Sponsors & Collaborators

• University of Faisalabad: lead

Study Sites (1)

Dr Rubina Zulfqar

Faisalabad, Punjab Province, 38000, Pakistan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Dr. Rubina Zulfqar

CONTACT

+923414291664; drrubinazulfqar355@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: July 10, 2026
• Study Start: July 7, 2026
• Primary Completion (Estimated): August 5, 2026
• Study Completion (Estimated): August 5, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

PA (1)